Starlix

Last updated on RxList: 4/8/2021
Starlix Side Effects Center

What Is Starlix?

Starlix (nateglinide) is an oral diabetes medicine used together with diet and exercise to treat type 2 (non-insulin dependent) diabetes. Other diabetes medicines are sometimes used in combination with Starlix if needed. Starlix is available in generic form.

What Are Side Effects of Starlix?

Common side effects of Starlix include:

Starlix can cause low blood sugar (hypoglycemia). Tell your doctor if you have symptoms of low blood sugar such as:

  • chills,
  • cold sweat,
  • dizziness,
  • drowsiness,
  • shaking,
  • fast heartbeat,
  • weakness,
  • headache,
  • fainting,
  • tingling of the hands or feet, or
  • hunger.
Tell your doctor if you have serious side effects of Starlix including:

Dosage for Starlix

The recommended starting and maintenance dose of Starlix, alone or in combination with metformin or a thiazolidinedione, is 120 mg three times daily before meals.

What Drugs, Substances, or Supplements Interact with Starlix?

Hyperglycemia (high blood sugar) may result if you take Starlix with drugs that raise blood sugar, such as: isoniazid, diuretics (water pills), steroids, phenothiazines, thyroid medicine, birth control pills and other hormones, seizure medicines, and diet pills, or medicines to treat asthma, colds or allergies. Hypoglycemia (low blood sugar) may result if you take Starlix with drugs that lower blood sugar, such as: non-steroidal anti-inflammatory drugs (NSAIDs), aspirin or other salicylates, sulfa drugs, monoamine oxidase inhibitors (MAOIs), beta-blockers, or probenecid. Tell your doctor all medications you use.

Starlix During Pregnancy and Breastfeeding

During pregnancy, Starlix should be used only when prescribed. Pregnancy may cause or worsen diabetes. Discuss a plan with your doctor to manage blood sugar while pregnant. Your doctor may change diabetes treatment during your pregnancy. It is not known if this drug passes into breast milk. Consult your doctor before breastfeeding.

Additional Information

Our Starlix (nateglinide) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

SLIDESHOW

Type 2 Diabetes: Signs, Symptoms, Treatments See Slideshow
Starlix Consumer Information

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Get emergency medical help if you have signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

  • seizure (convulsions); or
  • jaundice (yellowing of the skin or eyes).

Common side effects may include:

  • runny or stuffy nose, sneezing, cough, cold or flu symptoms;
  • diarrhea;
  • back pain;
  • dizziness; or
  • joint pain or stiffness.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Starlix (Nateglinide)

QUESTION

______________ is another term for type 2 diabetes. See Answer
Starlix Professional Information

SIDE EFFECTS

The following serious adverse reaction is also described elsewhere in the labeling:

  • Hypoglycemia [see WARNINGS AND PRECAUTIONS]

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

In clinical trials, approximately 2,600 patients with type 2 diabetes mellitus were treated with STARLIX. Of these, approximately 1,335 patients were treated for 6 months or longer and approximately 190 patients for one year or longer.

Table 1 shows the most common adverse reactions associated with STARLIX.

Table 1: Adverse Reactions other than Hypoglycemia (%) occurring Greater than or Equal to 2% in STARLIX-Treated Patients from Pool of 12 to 64 week Placebo Controlled Trials

Placebo
N = 458
STARLIX
N = 1441
Preferred Term
Upper Respiratory Infection 8.1 10.5
Back Pain 3.7 4.0
Flu Symptoms 2.6 3.6
Dizziness 2.2 3.6
Arthropathy 2.2 3.3
Diarrhea 3.1 3.2
Accidental Trauma 1.7 2.9
Bronchitis 2.6 2.7
Coughing 2.2 2.4

Hypoglycemia

Episodes of severe hypoglycemia (plasma glucose less than 36 mg/dL) were reported in two patients treated with STARLIX. Non-severe hypoglycemia occurred in 2.4 % of STARLIX treated patients and 0.4 % of placebo-treated patients [see WARNINGS AND PRECAUTIONS].

Weight Gain

Patients treated with STARLIX had statistically significant mean increases in weight compared to placebo. In clinical trials, the mean weight increases with STARLIX 60 mg (3 times daily) and STARLIX 120 mg (3 times daily) compared to placebo were 1.0 kg and 1.6 kg respectively.

Laboratory Test

Increases In Uric Acid

There were increases in mean uric acid levels for patients treated with STARLIX alone, STARLIX in combination with metformin, metformin alone, and glyburide alone. The respective differences from placebo were 0.29 mg/dL, 0.45 mg/dL, 0.28 mg/dL, and 0.19 mg/dL.

Postmarketing Experience

The following adverse reactions have been identified during post-approval use of STARLIX. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

  • Hypersensitivity Reactions: Rash, itching, and urticaria
  • Hepatobiliary Disorders: Jaundice, cholestatic hepatitis, and elevated liver enzymes

DRUG INTERACTIONS

Table 2 includes a list of drugs with clinically important drug interactions when concomitantly administered or withdrawn with STARLIX and instructions for managing or preventing them.

Table 2: Clinically Significant Drug Interactions with STARLIX

Drugs That May Increase the Blood-Glucose-Lowering Effect of STARLIX and Susceptibility to Hypoglycemia
Drugs: Nonsteroidal anti-inflammatory drugs (NSAIDs), salicylates, monoamine oxidase inhibitors, non-selective beta-adrenergic-blocking agents, anabolic hormones (e.g., methandrostenolone), guanethidine, gymnema sylvestre, glucomannan, thioctic acid, and inhibitors of CYP2C9 (e.g., amiodarone, fluconazole, voriconazole, sulfinpyrazone) or in patients known to be poor metabolizers of CYP2C9 substrates, alcohol.
Intervention: Dose reductions and increased frequency of glucose monitoring may be required when STARLIX is coadministered with these drugs.
Drugs and Herbals That May Reduce the Blood-Glucose-Lowering Effect of STARLIX and Increase Susceptibility to Hyperglycemia
Drugs: Thiazides, corticosteroids, thyroid products, sympathomimetics, somatropin, somatostatin analogues (e.g., lanreotide, octreotide), and CYP inducers (e.g., rifampin, phenytoin and St John’s Wort).
Intervention: Dose increases and increased frequency of glucose monitoring may be required when STARLIX is coadministered with these drugs.
Drugs That May Blunt Signs and Symptoms of Hypoglycemia
Drugs: beta-blockers, clonidine, guanethidine, and reserpine
Intervention: Increased frequency of glucose monitoring may be required when STARLIX is coadministered with these drugs.

Read the entire FDA prescribing information for Starlix (Nateglinide)

© Starlix Patient Information is supplied by Cerner Multum, Inc. and Starlix Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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